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DCC recommends SLAs to take action and submit report to CDSCO on AMR
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Gireesh Babu, New Delhi
April 23 , 2024
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The Drugs Consultative Committee (DCC) has recommended to the state licensing authorities (SLAs) to take concrete action on antimicrobial resistance (AMR), submit action taken report to the central drug authority, among other measures to curb the menace of AMR in the country.
The Committee, in its last meeting held earlier this year, was considering a proposal for checking AMR as per the expectation of National Action Plan for containment of AMR (NAP-AMR) 2.0 considering AMR has been a serious and growing threat to public health globally.
It proposed the state drugs controller (SDC) to implement various measures uniformly, including developing and implementing mechanism for safe disposal of expired antimicrobials, expansion of track and trace system, which was implemented on top 300 brands with effect from August 1, 2023, to more drugs, as part of curbing the AMR.
It also advised the develop guidelines to ensure quality management system to be implemented by the Central Drugs Standard Control Organisation (CDSCO) and SDCs, development of guidance for SDC authorities to ensure implementation of Schedule H and H1 drugs through enforcement activities and issuing advisory to manufacturers to use their digitalised well developed supply chain network, for manufacture and sale of antimicrobials.
The Committee opined that SLAs shall issue directions to manufacturing associations, chemist associations and enforcement officials for sensitizing them regarding the issue and visible concrete action need to be taken by the states.
"It was decided that each state shall provide an Action Taken Report on AMR to CDSCO. Further, CDSCO will also hold a dedicated consultation with states on the issue. States shall share the practices followed by them presently to combat AMR," said the minutes of the DCC meeting.
The Committee observed that the problem of AMR has been highlighted as a global health priority in multiple high-level fora ranging from the UNGA, G7 to G20.
Under the Indian Presidency, the G-20 New Delhi Leaders Declaration stated, “Implement and prioritise tackling antimicrobial resistance (AMR) following the One Health approach, including through research and development, infection prevention and control, as well as antimicrobial stewardship efforts within respective national action plans through AMR and antimicrobial consumption surveillance.”
The committee, during the meeting, also called for implementation of provisions of waste disposal available in the revised Schedule M in letter and spirit and measures involving State drug regulators for waste management to address the issue of AMR.
Considering issues related to pharmaceutical waste management, it proposed creation of dedicated nodal cells in each States to handle issues related to AMR.
The Committee opined that provisions of waste disposal are available in the revised Schedule M and emphasised that the same need to be implemented in letter spirit. It was also opined that it needs to be addressed by the drugs inspectors while carrying out the inspections, especially the manufacturing units which are into production of antimicrobials.
Considering disposal of the antimicrobials specifically on account of growing concerns regarding antimicrobial resistance being developed in the general population, States were also requested to provide inputs regarding current practices in their respective jurisdiction.
“Further, it was proposed to create dedicated nodal cell at each state level for handling issues related to antimicrobial resistance. It was further opined that states will be requested to share current practices on the disposal of antimicrobial drugs and accordingly a SOP will be prepared by CDSCO and shared to states for their comments,” it opined.
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